SWEET CHEEKS- zinc oxide ointment Saje Natural Business Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Sweet cheeks Active ingredient Zinc Oxide 12% Purpose Skin protectant Uses helps treat and prevent diaper rash. protects chafed skin or minor skin irritations due to diaper rash. seals out wetness. Warnings Warnings -Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days. Warnings -Do not use if allergic to plants of the marshmallow or asteraceae/compositae/daisy family. Warnings -When using this product, avoid contact with the eyes and mucous membranes. Warnings -Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Directions -Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. -Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. Other information -Store at room temperature. Inactive ingredients Olive oil, beeswax (yellow), butyrospermum parkii (shea) butter, coconut oil, castor oil, aloe barbadensis leaf extract, glycerin, vitamin e, calendula officinalis flower extract, hypericum perforatum flower extract (st john's wort), sunflower oil, rosmarinus officinalis (rosemary) leaf extract, echinacea angustifolia extract, camellia sinensis leaf extract (green tea), althaea officinalis root (marshmallow root), daucus carota sativa (carrot) seed oil, lavender oil Questions? 1-877-275-7253 Principal display panel information daily diaper rash ointment net wt. 75g (2.7 oz) and net wt. 30g (1oz) daily diaper rash ointment Sweet cheeks daily diaper rash ointment-Outer label SWEET CHEEKS zinc oxide ointment Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:70 9 8 3-0 21 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 g in 75 g Inactive Ingredients Ingredient Name Strength SHEA BUTTER (UNII: K49 155WL9 Y) CO CO NUT O IL (UNII: Q9 L0 O73W7L) YELLO W WAX (UNII: 2ZA36 H0 S2V) CASTO R O IL (UNII: D5340 Y2I9 G) SUNFLO WER O IL (UNII: 3W1JG79 5YI) TO CO PHERO L (UNII: R0 ZB2556 P8 ) HYPERICUM PERFO RATUM FLO WER (UNII: A6 V4CUE7PV) LAVENDER O IL (UNII: ZBP1YXW0 H8 ) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) GLYCERIN (UNII: PDC6 A3C0 OX) O LIVE O IL (UNII: 6 UYK2W1W1E) CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD) RO SEMARY (UNII: IJ6 7X351P9 ) ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 ) GREEN TEA LEAF (UNII: W2ZU1RY8 B0 ) ALTHAEA O FFICINALIS RO O T (UNII: TRW2FUF47H) CARRO T SEED O IL (UNII: 59 5AO13F11) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70 9 8 3-0 21-0 1 1 in 1 BOX 0 2/15/20 18 1 75 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct 2 NDC:70 9 8 3-0 21-0 2 30 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct 0 2/15/20 18 Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part347 0 2/15/20 18 Labeler - Saje Natural Business Inc. (203413380) Revised: 2/2018 Saje Natural Business Inc..